Lecture 4 - capsule formation

Question 1

Tests used in capsule formation

Answer 1

Disintegration
dissolution
weight uniformity
content uniformity

Question 2

Hard gelatin capsules
what is the shell like
content
manufacture
and closure

Answer 2

Low plasticiser (0.4 : 1 plasticiser to gelatin)
usually dry solids,
shells made then filled separate,
friction-fit

Question 3

Advantages of hard gelatin capsules

Answer 3

Better bioavailability,
rapid drug release and no need for compaction
easier to formulate than tablets
no taste

Question 4

Disadvantages of hard gelatin capsules

Answer 4

Slower process,
expense,
not suitable for highly soluble / hygroscopic substances,
maintain shell moisture content (12 – 15%)

Question 5

What is gelatin produced from

Answer 5

hydrolysed collagen from animal connective tissue, bone gelatin(Type B – alkaline hydrolysis),
skin gelatine (Type A – acid hydrolysis) and sinew.

Types can be combined to achieve best characteristics (A – plasticity + clarity, B – firmness)

Question 6

What is bloom strength in hard gelatin capsules

Answer 6

cohesive gel strength,
viscosity,
measured using gleometer.

Question 7

What are the 6 main steps for hard manufacturing capsules

Answer 7

dipping,
spinning,
drying,
stripping,
cutting,
joining

Question 8

FILL VOLUMES

Answer 8

000 = 1.37
00 = 0.95
0 = 0.67
1 =0.48
2=0.37
3=0.27
4 = 0.20
5 = 0.13

Question 9

Design of Hard Gelatin Capsule for Powder Fill
Requirements for the optimum design:

Answer 9

stability,
manufacturability,
patient compliance,
stability,
drug content uniformity

Question 10

Filling blend for hard gelatin capsules

Answer 10

API,
filler,
glidants,
lubricant,
disintegrant,
surfactants

Question 11

Soft gel capsules
what is the shell like
content
manufacture
and closure

Answer 11

Plasticised shell (0.8 : 1 plasticiser to gelatin)
usually solutions,
single process,
hermetically sealed

Question 12

SOFT GELATIN CAPSULES
ADVANTAGES

Answer 12

high reproducibility,
content uniformity and bioavailability,
suitable for liquids / volatile drugs

Question 13

SOFT GELATIN CAPSULES
DISADVANTAGES

Answer 13

limited expertise, equipment,
additional quality control, shell / content interaction

Question 14

Manufacture process of soft gelatin capsule

Answer 14

Rotary die

Question 15

Requirements for the Filling Liquid:
SOFT GEL CAPSULES

Answer 15

liquid pH 2.5 – 7.5,
non-aqueous emulsion (no leakage)

Question 16

Composition of the shell SOFT GELATIN

Answer 16

Gelatin
Plasticizer: glycerin, sorbitol, propylene glycol
Dyes
Opacifiers
Preservatives
Flavours